Quality of research
UMC Utrecht strives for socially robust scientific research in which society participates, and that makes use of the best and most appropriate methods. We strive to make a significant impact in this way, both for our patients and regionally and (inter)nationally. Excellent quality and compliance with laws and regulations are the basis for this.
New rules for drug and medical-device trials
The Medical Device Regulation (MDR) on medical-device trials and the Clinical Trial Regulation (CTR) on drugs trials came into force in 2021. Also in 2022, based on our own and countrywide insights, we continued to develop and improve the procedures established for research in this regard. This also prepares us for the fact that from 2023, we will be required to submit new drug trials under the CTR via the central Clinical Trials Information System portal (CTIS).
Quality manual for research
At the start of 2022 we published the quality manual for research on human subjects.
The manual gives researchers and research assistance a quick and clear overview of the steps and working instructions for each research phase. In 2022 we also extended the manual to research without human subjects, for instance pre-clinical studies. The quality manual is continuously updated and improved with new templates and working instructions.
Electronic consent
From July 1, 2022, it will be permitted, under certain conditions, to electronically sign the "consent form" for participation in scientific research under the Medical Research Involving Human Subjects Act (WMO). In 2022, we made preparations for this to safely start in 2023 and in ways allowed by law.
Continuous improvement
As part of research quality assurance, UMC Utrecht has an internal audit program that uses tracers to examine 1) research itself and 2) research leadership (the role and responsibilities of leadership within the division). In 2022, we conducted the research tracers thematically, focusing on data management and privacy. In leadership tracers, we not only looked at quality, but also our ambitions in terms of Open Science, diversity and inclusiveness, and patient participation. In the first half of 2023 we are evaluating the outcome of these tracers.
